Balixafortide
Also known as: Balixafortide, POL6326
Source Balixafortide at Peptiology
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Summary
Balixafortide (POL6326) is a synthetic cyclic peptide CXCR4 antagonist under clinical investigation for metastatic breast cancer, other solid tumors, and for hematopoietic stem‑cell mobilization. It is administered subcutaneously and has shown a manageable safety profile in early‑phase trials.
Mechanism of Action
Selective, high‑affinity antagonist of the CXCR4 receptor, blocking CXCL12 (SDF‑1) binding and downstream signaling, thereby inhibiting tumor cell migration, metastasis, and promoting hematopoietic stem‑cell mobilization.
Routes of Administration
Goals & Uses
- Hematopoietic stem cell mobilizationHematologyModerate
- Mobilize hematopoietic stem cellsTransplantationModerate
- Anti-tumor activity in HER2-negative metastatic breast cancerOncologyModerate
- Inhibition of tumor metastasis via CXCR4 blockadeOncologyModerate
- Sensitization of tumors to chemotherapyOncologyLow
- Inhibit tumor metastasisOncologyModerate
Contraindications
- Severe hepatic impairmentOrganModerateLiver function concerns
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Known hypersensitivity to balixafortide or excipientsAllergyHigh
- Hypersensitivity to balixafortide or excipientsAllergyHigh
Adverse Effects
- LeukocytosisHematologicUncommon
- HeadacheNeurologicUncommonPain in the head or upper neck
- HypotensionCardiovascularUncommonLow blood pressure
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- FatigueGeneralUncommonLow energy or tiredness
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
- Infusion-related reactionsHypersensitivityCommon
Drug Interactions
- EribulinLow
- G‑CSF agentsModerate
- CYP3A4 substratesLow
- Other CXCR4 antagonists (e.g., plerixafor)Moderate
Population Constraints
- Patients with active autoimmune conditionsImmunologicRelative
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
- Patients with severe renal impairmentOrgan ImpairmentRelative
Regulatory Status
- European UnionInvestigationalUnder EMA review for clinical trial authorization.
- United StatesInvestigationalPhase II/III trials ongoing; not FDA‑approved.
- United KingdomInvestigationalMHRA clinical trial approval only.
Not approved by FDA, EMA, or MHRA. Currently in Phase II/III clinical trials in several jurisdictions.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Balixafortide?
Balixafortide (POL6326) is a synthetic cyclic peptide CXCR4 antagonist under clinical investigation for metastatic breast cancer, other solid tumors, and for hematopoietic stem‑cell mobilization. It is administered subcutaneously and has shown a manageable safety profile in early‑phase trials.
What is Balixafortide used for?
Balixafortide is educationally associated with: Hematopoietic stem cell mobilization, Mobilize hematopoietic stem cells, Anti-tumor activity in HER2-negative metastatic breast cancer, Inhibition of tumor metastasis via CXCR4 blockade, Sensitization of tumors to chemotherapy, Inhibit tumor metastasis. Educational only — not medical advice.
How is Balixafortide administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Balixafortide?
Reported adverse effects include: Leukocytosis, Headache, Hypotension, Nausea, Fatigue, Injection site reaction, Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid Balixafortide?
Recorded contraindications: Severe hepatic impairment, Pregnancy, Known hypersensitivity to balixafortide or excipients, Hypersensitivity to balixafortide or excipients. Consult a qualified clinician before use.